PSMA Response in Metastasized Hormone Sensitive Prostate Cancer - Enzalutamide

Trial Title: PSMA Response in Metastasized Hormone Sensitive Prostate Cancer - Enzalutamide

NCT ID: NCT05539300

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Neoplasm Metastasis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: PSMA-PET/CT response evaluation
Description: PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy
Arm group label: PSMA response evaluation arm

Summary: PSMA-PET/CT response measurements after LHRH agonist and upfront enzalutamide therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.

Detailed description: Rationale: Men, newly diagnosed with metastasized prostate cancer on PSMA PET/CT, who start on standard hormonal therapy, are additionally treated with either upfront chemotherapy or upfront extra androgen-receptor targeted agents ('ARTA'), as per guidelines' recommendations. The benefit in overall survival of these two options is similar, but important differences exist in patient-specific efficacy, costs, side-effects, and impact on quality of life. No predictive factors are available to individualize treatment choice. Currently, a one-size-fits-all strategy with hormonal therapy plus chemotherapy is usually followed. Objective: To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice. Study design: Prospective, single arm, open label, non-interventional, non-therapeutic observational cohort study. Study population: Patients >18 years with newly diagnosed, histologically proven prostate cancer with >3 skeletal or visceral metastatic lesions on the PSMA-PET/CT, who are considered eligible for upfront therapy (enzalutamide) in addition to standard hormonal therapy. Main study parameters/endpoints: Primary parameter: Predictive value of early response on PSMA-PET/CT to upfront therapy, according to PERCIST criteria. Primary endpoint: Time to development of CRPC. Secondary parameters: Predictive value of early response on PSMA-PET/CT to hormonal therapy; predictive value of baseline PSMA-PET/CT, analysis of response in different subgroups of patients: e.g. high versus low tumour load, high versus low PSA, high versus low Gleason score. Secondary endpoint: Time to initiation of second line therapy after castration-resistant disease has been found. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Patients will be treated according to standard of care, including baseline PSMA-PET/CT. The timing of follow-up PSMA-PET/CT imaging will be standardized. Instead of imaging at biochemical or clinical signs of disease progression, one PSMA-PET/CT will be performed after two months of hormonal therapy, one PSMA-PET/CT will be performed after two months of upfront therapy. Each PSMA-PET/CT scan will require an extra visit (2-3 hours) and a limited radiation burden after intravenous injection of PSMA. The additional information from the standardized follow-up PSMA-PET/CT scans will not be used for clinical decision-making.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Men >18 years of age. - Mentally competent and understanding of benefits and potential burden of the study. - Written and signed informed consent. - Histological confirmed diagnosis of adenocarcinoma of the prostate. - Indicated to start on hormonal therapy (any LHRH agonist or antagonist). - Indicated to start on upfront therapy (enzalutamide). - Any initial PSA. - Any Gleason score. - Any T-stage. - Any N-stage. - Stage M1, with multiple / high volume metastasis: More than three (>3) metastatic lesions (any combination of either lymph node metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen on PSMA-PET/CT-imaging. As these patients are treated with palliative intent. Exclusion Criteria: - Concomitant malignancy (except from BCC of the skin). - History of prior diagnosed or treated PCa. - Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient's clinical status and/or outcome of the study. - Any known allergy for the upfront therapy. - Any known allergy for LHRH agonist or antagonist.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Roderick van den Bergh

Address:
City: Utrecht
Zip: 3583VS
Country: Netherlands

Status: Recruiting

Contact:
Last name: Roderick VD Bergh

Phone: 0623456800
Email: roodvdb@hotmail.com

Start date: March 1, 2023

Completion date: January 1, 2026

Lead sponsor:
Agency: UMC Utrecht
Agency class: Other

Source: UMC Utrecht

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05539300